A Randomized, Double-Blind, Placebo- and Positive-Controlled, Four-way Crossover Study to Investigate the Effects of Single Intravenous Doses of Difelikefalin (CR845) on the QTc Interval in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- QTc change from baseline following CR845 treatment.
研究概览
简要总结
This is a Phase 1, randomized, double-blind (except for moxifloxacin), placebo- and positive-controlled, single-site, 4-way crossover study to investigate the effects of single therapeutic and supratherapeutic IV doses of difelikefalin (CR845) on the QTc interval in healthy adult subjects. Subjects will be randomized to a treatment sequence consisting of 4 treatment periods with a minimum 5-day washout between treatments. Subjects will receive each of the study treatments over the course of the study. Randomized subjects will receive the assigned study treatment as a single dose in the fasted state in the morning on Day 1 of each treatment period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body weight between 50 to 120 kg and body mass index within 18 to 29 kg/m2 at Screening;
- •Current nonsmokers who have not used any tobacco- or nicotine-containing products (chewed or smoked) or replacement products, including, but not limited to, electronic cigarettes, in the 45 days prior to Screening.
排除标准
- •Past or present diseases, which as judged by the Investigator, may affect the outcome of this study;
- •Any condition or situation that, in the opinion of the Investigator, would prevent proper evaluation of the safety or efficacy of the study treatment according to the study protocol;
- •History of hypersensitivity or allergy to moxifloxacin or any other study treatment or history of tendonitis or tendon rupture with moxifloxacin or any other quinolone type drug.
研究组 & 干预措施
CR845 0.5 mcg/kg IV (Therapeutic Dose)
干预措施: CR845 0.5 mcg/kg IV (Drug)
CR845 3 mcg/kg IV (Supratherapeutic Dose)
干预措施: CR845 3 mcg/kg IV (Drug)
Placebo IV
干预措施: Placebo (Other)
Moxifloxacin 400 mg
干预措施: Moxifloxacin 400 mg Oral Tablet (Drug)
结局指标
主要结局
QTc change from baseline following CR845 treatment.
时间窗: Baseline, Day 1
次要结局
- Change from baseline in QTc with Bazett correction (QTcB).(Baseline, Day 1)
- Change from baseline in Heart Rate.(Baseline, Day 1)